Clinical Scientist Consultant

Job Description

Job Summary:

• Support the planning and execution of neurology clinical programs, including CIDP, through:
• Review of adjudication charters, endpoint assessment manuals, and related operational plans.
• Identification of clinical trial execution risks, operational gaps, and potential barriers to enrollment, data quality, and study delivery.
• Review of study start-up, site activation, enrollment, monitoring, vendor oversight, and participant-retention strategies.
• Assessment of protocol operational feasibility and support for protocol development and pivotal-study planning.
• Review of clinical data, protocol deviations, missing data, and emerging study trends to identify potential quality or execution concerns.
• Evaluation of site and vendor performance, including escalation pathways, roles and responsibilities, and operational accountability.
• Support for development of risk-mitigation plans, issue-management processes, and corrective and preventive actions, as appropriate.
• Cross-functional collaboration with Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, and external vendors.
• Support for regulatory preparation and inspection- or submission-readiness activities.